EnilloRing Dosage

2.1 How to Use EnilloRing

To achieve maximum contraceptive effectiveness, EnilloRing must be used as directed [see Dosage and Administration (2.2)]. One EnilloRing is inserted in the vagina. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.

The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down. The ring is to be compressed and inserted into the vagina. An optional alternative is to insert the ring using the applicator for EnilloRing [see Applicator for EnilloRing Instructions for Use ].The exact position of EnilloRing inside the vagina is not critical for its function. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks. This means that the ring should be removed three weeks later on the same day of the week as it was inserted and at about the same time.

EnilloRing can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out. The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet).

After a one-week break, during which a withdrawal bleed usually occurs, a new ring is inserted on the same day of the week as it was inserted in the previous cycle. The withdrawal bleed usually starts on Day 2-3 after removal of the ring and may not have finished before the next ring is inserted. In order to maintain contraceptive effectiveness, the new ring must be inserted exactly one week after the previous one was removed even if menstrual bleeding has not finished.

2.2 How to Start Using EnilloRing

IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of EnilloRing.

No Hormonal Contraceptive Use in the Preceding Cycle:
The woman should insert EnilloRing on the first day of her menstrual bleeding. EnilloRing may also be started on Days 2-5 of the woman’s cycle, but in this case a barrier method, such as male condoms with spermicide, should be used for the first seven days of EnilloRing use in the first cycle.

Changing From a CHC:
The woman may switch from her previous CHC on any day, but at the latest on the day following the usual hormone-free interval, if she has been using her hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant.

Changing From a Progestin-Only Method (progestin-only pill [POP], Implant, or Injection or a Progestin-Releasing Intrauterine System [IUS]):
The woman may switch from the POP on any day; instruct her to start using EnilloRing on the day after she took her last POP. She should switch from an implant or the IUS on the day of its removal, and from an injectable on the day when the next injection would be due. In all of these cases, the woman should use an additional barrier method such as a male condom with spermicide, for the first seven days.

Use After Abortion or Miscarriage:
The woman may start using EnilloRing within the first five days following a complete first trimester abortion or miscarriage, and she does not need to use an additional method of contraception. If use of EnilloRing is not started within five days following a first trimester abortion or miscarriage, the woman should follow the instructions for “No Hormonal Contraceptive Use in the Preceding Cycle.” In the meantime, she should be advised to use a non-hormonal contraceptive method.

Start EnilloRing no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism. [See Contraindications (4) and Warnings and Precautions (5.1).]

Following Childbirth:
The use of EnilloRing may be initiated no sooner than four weeks postpartum in women who elect not to breastfeed, due to the increased risk of thromboembolism in the postpartum period. [See Contraindications (4) and Warnings and Precautions (5.1).]

Advise women who are breastfeeding not to use EnilloRing but to use other forms of contraception until the child is weaned.

If a woman begins using EnilloRing postpartum, instruct her to use an additional method of contraception, such as male condoms with spermicide, for the first seven days. If she has not yet had a period, consider the possibility of ovulation and conception occurring prior to initiation of EnilloRing.

2.3 Deviations from the Recommended Regimen

To prevent loss of contraceptive efficacy, advise women not to deviate from the recommended regimen. EnilloRing should be left in the vagina for a continuous period of three weeks. Advise women to regularly check for the presence of EnilloRing in the vagina (for example, before and after intercourse).

Inadvertent Removal or Expulsion:
EnilloRing can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement. EnilloRing should be left in the vagina for a continuous period of three weeks. If the ring is accidentally expelled and is left outside of the vagina for less than three hours, contraceptive efficacy is not reduced. EnilloRing can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within three hours. If EnilloRing is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration.

If EnilloRing is out of the vagina for more than three continuous hours:

During Weeks 1 and 2: Contraceptive efficacy may be reduced. The woman should reinsert the ring as soon as she remembers. A barrier method such as male condoms with spermicides must be used until the ring has been used continuously for seven days.

During Week 3: The woman should discard that ring. One of the following two options should be chosen:
1. Insert a new ring immediately. Inserting a new ring will start the next three-week use period. The woman may not experience a withdrawal bleed from her previous cycle. However, breakthrough spotting or bleeding may occur.
2. Insert a new ring no later than seven days from the time the previous ring was removed or expelled, during which time she may have a withdrawal bleed. This option should only be chosen if the ring was used continuously for at least seven days prior to inadvertent removal/expulsion.

In either case, a barrier method such as male condoms with spermicides must be used until the new ring has been used continuously for seven days.

If EnilloRing was out of the vagina for an unknown amount of time, the possibility of pregnancy should be considered. A pregnancy test should be performed prior to inserting a new ring.

Prolonged Ring-Free Interval:
If the ring-free interval has been extended beyond one week, consider the possibility of pregnancy, and an additional method of contraception, such as male condoms with spermicide, MUST be used until EnilloRing has been used continuously for seven days.

Prolonged Use of EnilloRing:
If EnilloRing has been left in place for up to one extra week (i.e., up to four weeks total), the woman will remain protected. EnilloRing should be removed and the woman should insert a new ring after a one-week ring-free interval.

If EnilloRing has been left in place for longer than four weeks, instruct the woman to remove the ring, and rule out pregnancy. If pregnancy is ruled out, EnilloRing may be restarted, and an additional method of contraception, such as male condoms with spermicide, MUST be used until a new EnilloRing has been used continuously for seven days.

Ring Breakage:
There have been reported cases of EnilloRing disconnecting at the weld joint. This is not expected to affect the contraceptive effectiveness of EnilloRing. In the event of a disconnected ring, vaginal discomfort or expulsion (slipping out) is more likely to occur. Vaginal injury associated with ring breakage has been reported [see Adverse Reactions (6.2)].

If a woman discovers that her EnilloRing has disconnected, she should discard the ring and replace it with a new ring.

2.4 In the Event of a Missed Menstrual Period

1. If the woman has not adhered to the prescribed regimen (EnilloRing has been out of the vagina for more than three hours or the preceding ring-free interval was extended beyond one week), consider the possibility of pregnancy at the time of the first missed period and discontinue EnilloRing use if pregnancy is confirmed.

2. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

3. If the woman has retained one EnilloRing for longer than four weeks, rule out pregnancy.

2.5 Use with Other Vaginal Products

EnilloRing may interfere with the correct placement and position of certain female barrier methods such as a diaphragm, cervical cap or female condom. These methods are not recommended as back-up methods with EnilloRing use.

Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by EnilloRing.